Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children

Last updated: July 11, 2025
Sponsor: Gilead Sciences
Overall Status: Completed

Phase

2/3

Condition

Aids And Aids Related Infections

Hiv/aids

Hiv Infections

Treatment

E/C/F/TAF

E/C/F/TAF (Low Dose)

Clinical Study ID

NCT01854775
GS-US-292-0106
2013-002780-26
  • Ages 2-17
  • All Genders

Study Summary

The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 (Part B) in human immunodeficiency virus - 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive adolescents.

The primary objectives of Cohort 2 are to evaluate the PK of EVG and TAF in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg administered E/C/F/TAF STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg (Part B).

The primary objectives of Cohort 3 are to evaluate the PK of EVG and TAF and confirm the dose of the STR, and to evaluate the safety and tolerability of E/C/F/TAF low dose (LD) STR in virologically suppressed HIV-1 infected children ≥ 2 years of age and weighing ≥ 14 to < 25 kg.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Cohort 1

  • 12 years to < 18 years of age at baseline

  • Weight greater than or equal to 35 kg (77 lbs)

  • Plasma HIV-1 ribonucleic acid (RNA) levels of ≥ 1,000 copies/mL at screening (Roche COBAS TaqMan v2.0)

  • Screening genotype report shows sensitivity to EVG, FTC and tenofovir (TFV)

  • No prior use of any approved or experimental anti-HIV-1 drug for any length oftime

  • Cohort 2

  • 6 years to < 12 years of age at baseline

  • Weight greater than or equal to 25 kg (55 lbs)

  • Plasma HIV-1 RNA of < 50 copies/mL (or undetectable HIV-1 RNA level accordingto the local assay being used if the limit of detection is > 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviralregimen, without documented history of resistance to any component of E/C/F/TAFSTR.

  • Cohort 3

  • Age at baseline: ≥ 2 years old

  • Weight at screening: ≥ 14 kg (31 lbs) to < 25 kg (55 lbs)

  • Plasma HIV-1 RNA: < 50 copies/mL (or undetectable HIV-1 RNA level according tothe local assay being used if the limit of detection is > 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviralregimen, without prior history of resistance to any component of E/C/F/TAF STR

Exclusion

Key Exclusion Criteria:

  • Hepatitis B or hepatitis C virus infection

  • Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 monthsof the screening visit.

  • Individuals experiencing decompensated cirrhosis

  • Pregnant or lactating females

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 129
Treatment Group(s): 2
Primary Treatment: E/C/F/TAF
Phase: 2/3
Study Start date:
May 06, 2013
Estimated Completion Date:
June 18, 2025

Connect with a study center

  • Hospital Civil de Gualdalajara Fray Antonio Alcalde

    Guadalajara, Jalisco 44280
    Mexico

    Site Not Available

  • Be Part Yoluntu Centre

    Cape Town, 7646
    South Africa

    Site Not Available

  • Desmond Tutu HIV Foundation

    Cape Town, 7705
    South Africa

    Site Not Available

  • KIDCRU Ward J8

    Cape Town, 7505
    South Africa

    Site Not Available

  • Mpati Medical Centre

    Dundee, 3000
    South Africa

    Site Not Available

  • Gulam Latiff Private Practice

    Durban, 4001
    South Africa

    Site Not Available

  • Clinical HIV Research Unit

    Johannesburg, 2041
    South Africa

    Site Not Available

  • Empilweni Services and Research Unit (ESRU)

    Johannesburg, 2092
    South Africa

    Site Not Available

  • Perinatal HIV Research Unit Baragwanath Hospital

    Johannesburg, 1862
    South Africa

    Site Not Available

  • Perinatal HIV Research Unit

    Soweto, 2013
    South Africa

    Site Not Available

  • The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)

    Pathumwan, Bangkok 10330
    Thailand

    Site Not Available

  • Department of Pediatrics, Faculty of Medicine, Khon Kaen University

    Muang, Khon Kaen 40002
    Thailand

    Site Not Available

  • The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)

    Bangkok, 10330
    Thailand

    Site Not Available

  • Queen Savang Vadhana Memorial Hospital

    Chon Buri, 20110
    Thailand

    Site Not Available

  • Queen Savang Vadhana Memorial Hospital

    Chonburi, 20110
    Thailand

    Site Not Available

  • Department of Pediatrics, Faculty of Medicine, Khon Kaen University

    Khon Kaen, 40002
    Thailand

    Site Not Available

  • Joint Clinical Research Centre

    Lubowa Hill, Kampala PO Box 10005
    Uganda

    Site Not Available

  • Joint Clinical Research Centre

    Kampala, PO Box 10005
    Uganda

    Site Not Available

  • Miller's Children Hospital

    Long Beach, California 90806
    United States

    Site Not Available

  • Alta Bates Summit Medical Center

    Oakland, California 94609
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Children's Research Institute

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Children's National Medical Center

    Washington, D.C., District of Columbia 20852
    United States

    Site Not Available

  • University of South Florida - Department of Pediatrics

    Tampa, Florida 33606
    United States

    Site Not Available

  • Emory University School of Medicine

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • New York University

    New York, New York 10016
    United States

    Site Not Available

  • SUNY Upstate Medical Center

    Syracuse, New York 13210
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • St. Jude Children's Research Hospital

    Memphis, Tennessee 38105
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105-0371
    United States

    Site Not Available

  • University of Zimbabwe - Clinical Research Centre

    Belgravia, 263
    Zimbabwe

    Site Not Available

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